Effect of Clemastine Fumarate on Color Vision in Healthy Controls

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Clemastine fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT02613091

Clemastine Color Vision

Details and patient eligibility

About

In a1972 study in the French Annals of Pharmaceuticals, Laroche and Laroche reported that the drug clemastine has a negative effect on patients' color discrimination, which is the ability to distinguish different hues and arrange them in the correct order. In an upcoming clinical trial studying the effect of clemastine on vision outcomes, our lab aims to assess color visual performance adding assessment of color defectiveness as a clinical endpoint. Color defectiveness is the ability to see certain colors, and is commonly referred to as color-blindness. Color discrimination and defectiveness can be related, but do not always correlate. This study aims to detect the effect, if any, that clemastine has on color defectiveness in healthy controls, which could confound its use as an outcome endpoint in future clinical trials relating to clemastine.

Full description

Additional evaluation of pharmacokinetic data will be performed to confirm pharmacokinetic measures and correlate blood levels of drug to color performance if seen.

Enrollment: 23 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy control

Exclusion criteria

• Preexisting ophthalmologic conditions such as optic neuritis, macular star, glaucoma

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Clemastine

Experimental group

Description:

This group will receive 8mg of clemastine daily.

Treatment:

Drug: Clemastine fumarate